Senior Quality Engineer, Product Escalation

Company: J&J Family of Companies
Location: Raynham
Posted on: May 3, 2021

Job Description:

DePuy Synthes, companies of Johnson & Johnson, is recruiting for a Senior Quality Engineer, Product Escalation position for Product Issue Escalations, located at any J&J location/campus in North America or Europe with preference for the following DePuy-Synthes sites: Raynham, MA, Warsaw, IN, West Chester, PA or Palm Beach Gardens, FL. DePuy Synthes, part of the Johnson & Johnson Medical Devices Companies, provides one of the most comprehensive orthopedics portfolios in the world. DePuy Synthes solutions, in specialties including joint reconstruction, trauma, craniomaxillofacial, spinal surgery and sports medicine, are designed to advance patient care while delivering clinical and economic value to health care systems worldwide. For more information, visit . The Senior Quality Engineer (Product Escalations) will have responsibilities for operating companies under Medical Device Sector (DePuy-Synthes) with a variety of products in the areas of joint reconstruction, trauma, spine, sports medicine, neurological, craniomaxillofacial, power tools and biomaterials. The candidate should excel in an environment that embraces teamwork, change, risk-based decision-making, and flexibility. You should be able to communicate effectively at all levels within Quality as well as business partners within departments such as Medical Safety, R&D, Regulatory, Supplier Quality, Manufacturing, and Marketing. Key Responsibilities: The incumbent will be responsible for evaluating events and trends within the quality system, to assure safety, efficacy, and quality of products throughout their lifecycle through Product Quality & Health Risk Evaluations. She/he will: + Facilitate teams of multi-functional SMEs to execute root cause investigation and bounding, to assess regulatory and medical safety impact and review associated quality system records and risk documentation + Lead weekly reviews on open investigations with SMEs and representatives of the risk management board (RMB), drive timely actions and updates, facilitate identification of higher risk issues as early as possible, communicate to management on high-risk safety, quality, or compliance issues + Lead RMB and Quality Review Board (QRB) meetings; prepare presentations of each issue and guide quorum to a final vote; complete records and meeting minutes in a timely and compliant manner, route records for approvals + Liaison with field action team to ensure transition of QRB actions and documentation + Support Data Requests for post market surveillance, regulatory registrations, etc. + Support internal and external audits in preparation activities, backroom, and front room roles + Complete special assignments across DPS and/or HMD initiatives as requested Qualifications Education: + A minimum of bachelors degree is required, a Bachelor of Art or Science Degree in Science/Technical Field is preferred + An Advanced degree in a related field Required: + Minimum of 5 years in medical device supply chain or related experience + Prior experience in ISO 13485 and/or QSR 820 FDA regulated environment + Advanced skills on Microsoft Office software, including Word, Excel, PowerPoint + The ability to work independently and lead a multi-functional team + Prioritization of work to meet deadlines + Able to progress work forward in the face of ambiguity Preferred: + Quality Engineering/ Design or Process Excellence/ Lean Experience, ASQ or Six Sigma Certification, mechanical product knowledge + Experience in manufacturing and/or mechanical knowledge + Project management experience + An Advanced degree in a related field + Excellent interpersonal relations, negotiation, decision-making and communication skills that foster conflict resolution to technical situations Other: + This position may be located at any J&J location/campus in North America or Europe with preference for the following DePuy-Synthes sites: Raynham, MA, Warsaw, IN, West Chester, PA or Palm Beach Gardens, FL and will require up to 10% travel. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation. Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability. Primary Location United States-Pennsylvania-West Chester-1310 Goshen Parkway Other Locations Europe/Middle East/Africa, North America-United States-Indiana-Warsaw, North America-United States-Florida-Palm Beach Gardens, United States-Massachusetts-Raynham Organization Medical Device Business Services, Inc (6029) Job Function Engineering Requisition ID 2105922837W

Keywords: J&J Family of Companies, Brockton , Senior Quality Engineer, Product Escalation, Other , Raynham, Massachusetts